Product Code: ELL FDA class 2 21 CFR 872.3920

Teeth, Porcelain

Dental

Porcelain Teeth are high-fired ceramic artificial teeth used in the construction of complete and partial dentures, valued for their excellent aesthetic properties, color stability, hardness, and resistance to staining compared to acrylic resin alternatives. They are classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is ELL, regulated under 21 CFR 872.3920 in the Dental (DE) specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: ELL
Device Class: FDA class 2
Regulation Number: 872.3920
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 39 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240586	Additive Manufacturing Zirconia Customized Restoration	Oct 03, 2024	Substantially Equivalent	Hangzhou Thales Medtech Co., Ltd.
K203072	Franz Zirconia Dental Crown	Jan 19, 2022	Substantially Equivalent	Franz Biotech, Inc.
K162043	NobelProcera HT ML FCZ Bridge	Nov 22, 2016	Substantially Equivalent	Nobel Biocare AB
K153534	NobelProcera HT ML Full Contour Zirconia Crown	Jun 06, 2016	Substantially Equivalent	Nobel Biocare AB
K071182	PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013	Jul 11, 2007	Substantially Equivalent	Nobel Biocare AB
K060530	SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.	May 22, 2006	Substantially Equivalent	Lifecore Biomedical, Inc.
K041283	PROCERA BRIDGE ZIRCONIA	May 28, 2004	Substantially Equivalent	Nobel Biocare AB
K032562	PROCEARA COPINGS AND PONTIC	Feb 06, 2004	Substantially Equivalent	Nobel Biocare AB
K965216	ARGI-SATIN OR OPTI0-STAR	Feb 27, 1997	Substantially Equivalent	Argen Precious Metals, Inc.
K960770	MATCHMAKER/PROPAQUE PORCELAIN	Nov 19, 1996	Substantially Equivalent	Davis Schottlander & Davis, Ltd.
K960480	IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013	Mar 15, 1996	Substantially Equivalent	Vident
K930835	VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A	Jul 22, 1994	Substantially Equivalent	Ivoclar North America, Inc.
K932012	CAPS	Nov 03, 1993	Substantially Equivalent	Chemichl, Inc.
K931808	DUCERAGOLD, DUCERATIN	Nov 03, 1993	Substantially Equivalent	Degussa AG
K924823	MICRODOSE SILANE	Mar 16, 1993	Substantially Equivalent	Unicep
K924821	MICRODOSE PORCELAIN ETCHANT	Mar 16, 1993	Substantially Equivalent	Unicep
K923926	IPS CERAMIC ETCHING GEL	Oct 27, 1992	Substantially Equivalent	Ivoclar North America, Inc.
K920460	4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL	Apr 28, 1992	Substantially Equivalent	Pulpdent Corp.
K910569	TYCERAMIC	Apr 15, 1991	Substantially Equivalent	Jeneric/Pentron, Inc.
K910303	SYSNPAR PORCELAIN	Mar 08, 1991	Substantially Equivalent	Jeneric/Pentron, Inc.
K903907	PROCERAM PORCELAIN	Nov 09, 1990	Substantially Equivalent	Nobelpharma USA, Inc.
K895269	DEN-MAT LAMI-QUICK	Feb 22, 1990	Substantially Equivalent	Den-Mat Corp.
K893481	CRYSTAR(TM) ANTI-GREENING LIQUID	Jul 14, 1989	Substantially Equivalent	Shofu Dental Corp.
K892806	TUF-COAT	Jul 14, 1989	Substantially Equivalent	G-C Intl. Corp.
K884214	CRYSTAR(TM) VINTAGE PORCELAIN	Dec 08, 1988	Substantially Equivalent	Shofu Dental Corp.
K880774	SPECTRUM	May 18, 1988	Substantially Equivalent	Dentsply Intl.
K880764	G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER	Apr 12, 1988	Substantially Equivalent	G-C Intl. Corp.
K875351	DEN-MAT PORETCH (PORCELAIN ETCHANT)	Mar 18, 1988	Substantially Equivalent	Den-Mat Corp.
K871808	DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM	Jun 05, 1987	Substantially Equivalent	Degussa Dental, Inc.
K864724	MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN	Feb 17, 1987	Substantially Equivalent	Dentsply Intl.
K860608	ARTIFICIAL TEETH, PORCELAIN, MODIFIED	Mar 26, 1986	Substantially Equivalent	Dentsply Intl.
K851733	DENTAL PORCELAIN-VARIOUS	Oct 16, 1985	Substantially Equivalent	Excelco Intl., Inc.
K852145	CAPA PRE-FORMED PORCELAIN CROWN	Jul 02, 1985	Substantially Equivalent	Capa Industries
K841826	NATURA-DENT VACUUM-FIRED PORCELAIN TEETH	Jul 12, 1984	Substantially Equivalent	Parexel Intl. Corp.
K840642	THERMOCRAFT PORCELAIN	Mar 30, 1984	Substantially Equivalent	American Thermocraft Corp.
K823744	PORCELAIN ARTIFICIAL TEETH	Dec 28, 1982	Substantially Equivalent	Dentsply Intl.
K800829	MYERSON R&KENSON R PORCELAIN ANT&POS.-	May 08, 1980	Substantially Equivalent	Myerson Tooth Corp.
K781935	NU-GLAZE	Dec 20, 1978	Substantially Equivalent	Deringer-Ney, Inc.
K771179	BIOBOND MASTER STAIN AND GLAZE KIT	Jul 15, 1977	Substantially Equivalent	Dentsply Intl.